Stroke Clinical Trial
Official title:
Stroke Telemedicine for Arizona Rural Residents Trial
The STARR network registry consists of a 4 spoke 1 hub system. Which will consist of prospective collection, recording, and regular analysis of telestroke patient consultation and care data for the purpose of quality measure assessment and improvement and benchmarking against other national and international telestroke programs.
Background:
Acute stroke resources and care are deficient in Arizona's rural communities. Stroke
telemedicine is a proven modality for overcoming the deficiency. Stroke telemedicine allows
a telephonic consultation and/or two-way audio video consultation between a stroke
neurologist and a stroke patient at a remotely located emergency department. University of
California San Diego Stroke Center has completed an NIH funded randomized controlled trial,
STRokE DOC, comparing telephonic consultations to video consultations. In that trial, video
telemedicine consultations resulted in more accurate decision making compared with telephone
consultations. The video telemedicine consultative modality provides the rural stroke
patient with the opportunity to receive expert stroke care, interpretation of neuroimaging,
determination of appropriate acute therapy, and recommendations regarding need for transfer
to a higher level of care. Mayo Clinic Arizona is currently completing a state funded
feasibility trial, STRokE DOC Arizona (06-005731), as a preliminary step toward establishing
a state wide stroke telemedicine network, STARR. The STARR network plan should include the
prospective collection, recording, and regular analysis of telestroke patient consultation
data for the purpose of quality measure assessment and improvement.
Objective:
The objective of this research is to establish a system for the prospective collection,
recording, and regular analysis of telestroke patient consultation and care data for the
purpose of quality measure assessment and improvement and benchmarking against other
national and international telestroke programs.
Methods:
The STARR network consists of a primary stroke center hub (Mayo Clinic Hospital) that serves
multiple spoke hospitals in remote and rural regions of the state (e.g. Kingman and Yuma
Regional Medical Centers, La Paz Regional Hospital and Copper Queen Community Hospital).
Mayo Clinic vascular neurologists, who have licenses and privileges to practice
teleneurology at spoke hospitals in the state, participate in a 24/7 Mayo Clinic telestroke
hotline. When an acute stroke patient presents to a STARR network participating spoke
hospital emergency department, a stroke alert is activated and the hotline is phoned. An
on-call vascular neurologist receives the pager notification and communicates with the
referring emergency physician. The telestroke consultation will begin by telephone and will
be supplemented by audio-video telemedicine communication and teleradiology. The patient is
registered at Mayo Clinic and a registration number is generated by the house supervisor.
Emergency neurology care is rendered. Every participating spoke hospital emergency physician
is already a sub-investigator in telestroke research and has completed HSRP training and
certification. The Mayo Clinic IRB has served as the central IRB of record for state funded
Mayo Clinic telestroke research. The patient or legal designate will be approached by either
the spoke emergency physician investigator and/or the hub neurologist investigator (via
telemedicine camera) for consent to proceed with telestroke consultation, and to acquire,
store, and analyze data concerning the acute stroke care and outcome of the patient. Data
sources will include the Mayo Clinic electronic transcribed telestroke consultation note,
the emergency department nursing and physician records, the admission consultation and
diagnostic tests records, hospital discharge note, and the content of a brief 90 day
follow-up phone call by the research coordinator to patient and/or family member. The
licensed neurologists already have authorization to access patient spoke hospital records as
part of their clinical privileges, but the designated Mayo Clinic research coordinator will
have the responsibility to extract data from the sources and enter it into the registry. The
STARR registry data elements will be exactly the same as the established and familiar data
elements for the STRokE DOC Arizona trial, for the purposes of continuity. Mayo Clinic
Arizona research biostatistics group will develop the electronic data manager and conduct
and report analyses monthly to the telestroke research group.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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